NCT02233595

Brief Summary

The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

September 3, 2014

Last Update Submit

August 8, 2019

Conditions

Rectal Adenocarcinoma

Keywords

MRIPETrectal canceradjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

  • change in SUVmax

    To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response

    2 months

  • tumor volume

    To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response

    2 months

Study Arms (1)

Adjuvant chemotherapy

Radiation: Chemoradiation

Interventions

ChemoradiationRADIATION
Adjuvant chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 patients with newly diagnosed rectal adenocarcinoma

You may qualify if:

  • A diagnosis of histopathologically confirmed rectal adenocarcinoma.
  • Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
  • Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
  • Age ≥18.
  • Ability to understand a written informed consent document and the willingness to sign it.
  • Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
  • Neoadjuvant chemoradiation prior to resection is planned..
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

You may not qualify if:

  • ERUS tumor state of T1.
  • Radiographic evidence of metastatic disease
  • Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
  • Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
  • Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
  • Prior history of pelvic radiation.
  • Uncontrolled hyperglycemia (defined as inability to achieve a glucose of \<250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
  • Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) \< 30 mLs/min), which is a contraindication to gadolinium containing contrast.
  • Known allergy to gadolinium containing contrast agents.
  • Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
  • Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Imaging Center at China Basin

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Thomas Hope, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 8, 2014

Study Start

October 15, 2014

Primary Completion

January 28, 2018

Study Completion

January 28, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

US(1)